Sterile caps for a liquid drainage system and method

ABSTRACT

A pair of sterile nestable closure caps having a female end and a male end, and a method of aseptically protecting the interconnectable ends of first and second tubes in a liquid drainage system with the caps. In the method, the ends of the first and second tubes are disconnected, the end of the second tube is inserted into the female end of the sterile nested caps, and the male end of the sterile nested caps is inserted into the end of the first tube to close the ends of the first and second tubes. The nested caps are then separated, whereby the ends of the disconnected first and second tubes are aseptically closed by the caps.

[ Sept. 17, 1974 STERllLE CAPS FOR A LIQUID DRAINAGE SYSTEM AND METHOD[75] Inventor: Frank K. Villari, Oak Park, Ill.

[73] Assignee: The Kendall Company, Walpole,

Mass.

22 Filed: Feb. 20, 1973 211 Appl.N0.:333,909

[52] US. Cl 128/349 R, 128/295, 206/632 [51] Int. Cl A6lm 25/00 [58]Field of Search 128/275, 295, 348, 349 R,

128/350 R, 227; 206/632, 56 R, 65 R; D83/1 Vaillancourt ct al. [28/349 RTarzana D83/l Primary Examiner-Dalton L. Truluck Attorney, Agent, orFirm-Powell L. Sprunger 5 7 ABSTRACT A pair of sterile nestable closurecaps having a female end and a male end, and a method of asepticallyprotecting the interconnectable ends of first and second tubes in aliquid drainage system with the caps. 1n the method, the ends of thefirst and second tubes are disconnected, the end of the second tube isinserted into the female end of the sterile nested caps, and the maleend of the sterile nested caps is inserted into the end of the firsttube to close the ends of the first and second tubes. The nested capsare then separated, whereby the ends of the disconnected first andsecond tubes' are aseptically closed by the caps.

13 Claims, 11 Drawing Figures PATENTEDSEPI mu SHEET 1 BF 2 FIG. I

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STERILE CAPS FOR A LIQUID DRAINAGE SYSTEM AND METHOD BACKGROUND OF THEINVENTION Various systems for draining a body cavity of a patient areknown, such as a urinary drainage system which is used to drain urinefrom the bladder. In a urinary system in common use, the distal end of acatheter is inserted through the urethra into the bladder with theproximal end of the catheter remaining outside of the patients body. Oneend of a drainage tube is connected to the proximal end of the catheter,and urine drains from the catheter through the drainage tube into acollection bag which is connected to the other end of the drainage tube.It is important to prevent contamination to the drainage system duringcatheterization, due to possible retrograde movement of bacteria intothe bladder which may cause infection in the patient. Accordingly, manyof such systems are closed to the atmosphere to exclude bacteria fromthe systems.

It is sometimes desirable to disconnect the catheter from the drainagetube during catheterization, for example, to permit the patient to leavethe bedside without the necessity of carrying the drainage bag. However,difficulty has been encountered in maintaining the systems in a sterilecondition during such a procedure, and it is found necessary to protectthe ends of the catheter and drainage tube from contamination the timethat they are disengaged from each other to prevent contamination to thesystem.

A catheter plug and shield device is disclosed in Strawn US. Pat. No.3,307,552.

SUMMARY OF THE INVENTION A principal feature of the present invention isthe provision of a pair of sterile caps and a method of asepticallyprotecting the interconnectable ends of first and second tubes in aliquid drainage system with the caps in a convenient and simplifiedmanner.

The sterile caps of the present invention are nestable, with the nestedcaps having a female end and a male end. According to the method of thepresent invention, the ends of the first and second tubes aredisconnected, the end of the second tube is inserted into the female endof the sterile nested caps, the male end of the sterile nested caps isinserted into the end of the first tube, and the nested caps are thendisconnected.

Thus, a feature of the invention is that the ends of the disconnectedfirst and second tubes are aseptically closed by the caps.

Another feature of the invention is that in a preferred embodiment eachof the closure caps has a male end and a female end, such that the maleend of either of the caps is nestable in the female end of the other ofthe caps.

Further features will become more fully apparent in the followingdescription of the embodiment of this invention and from the appendedclaims.

DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is perspective viewof the nestable closure caps of the present invention in a nestedconfiguration;

FIG. 2 is a sectional view of the closure caps of FIG.

FIG. 3 is a perspective view of the closure caps of FIG. 1 as retainedin a partially opened sterile package;

- FIG. 4 is a fragmentary perspective view of a liquid drainage systemshowing the proximal end of a catheter being disconnected from thedistal end of a drainage tube in the system;

FIG. 5 is a fragmentary perspective view showing the distal end of thedrainage tube beinginserted into the nested closure caps of FIG. 3;

FIG. 6 is a fragmentary perspective view showing the nested closure capsbeing inserted into the catheter;

FIG. 7 is a fragmentary perspective view showing the nested closure capsbeing disconnected from each other;

FIG. 8 is a fragmentary perspective view showing a closure cap beingremoved from the distal end of the drainage tube;

FIG. 9 is a fragmentary perspective view showing a closure cap beingremoved from the proximal end of the catheter;

FIG. 10 is a fragmentary perspective view showing the catheter beingreconnected to the drainage tube; and

FIG. 11 is a perspective view showing the closure caps being reconnectedfor disposal.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIGS. 1 and 2,there is shown a pair of nestable closure caps 10a and 10b, which areillustrated in their nested configuration. In a preferred embodiment,each of the closure caps comprises a hollow generally conically shapedmember, such that the closure caps 10a and b have cavities or recesses12a and 12b, respectively, extending from female ends 14a and 14b,respectively, of the caps, while male ends 16;: and 16b, respectively,are defined adjacent the other end of the caps. In the nestedconfiguration, the male end 16a of an inner cap 10a is received in thefemale end 14b of an outer cap 10b, such that the nested capsinterengage and are releasably retained together. The nested caps have afemale end 14a which is defined by the inner cap 10a and a male end 16bdefined by the outer cap 10b. Preferably, both of the caps have the sameshape, in order that the male end of either of the caps may be nested inthe female end of the other of the caps.

The nested caps may be sterilized and may be aseptically retained in asterile package known to the art, such as the peel package 18 shown inFIG. 3. The package 18 has a pair of sheets 20a and 20b sealed togetheradjacent their edges, and one end of the upper sheet is peeled back toexpose the female end 14a of the nested caps prior to use, as shown.

The proximal end 36 of a catheter or first tube 30 and the distal end 40of a drainage or second tube 32 in a liquid drainage system isillustrated in FIG. 4. The catheter 30 has a main lumen 34 extendingthrough the catheter to its proximal end 36, while the drainage tube 32has a drainage lumen 38 extending through the drainage tube to itsdistal end 40. During use of the drainage system, the proximal end 36 ofthe catheter 30 is connected with the distal end 40 of the drainage tube32 with the lumens 34 and 38 in communication, such that liquid drainsfrom the catheter 30 through a drainage lumen to a collection bag (notshown). Preferably, the drainage tube 32 has a connector 42 adjacent itsdistal end 40 to facilitate connectability of the drainage tube with thecatheter.

The closure caps are utilized to protect the drainage system fromcontamination, as described below. First, the sterile package 18 may beopened to expose the female end 14a of the sterile nested caps, aspreviously described in connection with FIG. 3. Next, the catheter maybe pinched by a users fingers adjacent its proximal end 36 to close themain lumen 34 and prevent further drainage through the catheter, and theends of the catheter and drainage tube are disconnected, as illustratedin FIG. 4. As shown in FIG. 5, the distal end 40 or connector 42 of thedrainage tube 32 is then inserted into the female end 14a of the sterilenested caps. After the distal end 40 of the drainage tube 32 is engagedin the nested caps, the nested caps are removed from the package 18 bywithdrawing the drainage tube 32 without the necessity of touching thecaps with the users hands. As shown in FIG. 6, the male end 16b of thenested caps is then inserted into the proximal end 36 of the catheter 30by pushing the nested caps into this position while the user grasps thedrainage tube 32 and catheter 30. Finally, the caps a and b areseparated by twisting the drainage tube 32 and catheter 30 slightly,relative to each other, and pulling the catheter 30 away from thedrainage tube 32, as illustrated in FIG. 7.

Thus, the cap 10a remains on the drainage tube 32 and closes its distalend 40 from the atmosphere to prevent contamination while the drainagetube 32 is disconnected from the catheter 30. Similarly, the closure cap10b remains in the catheter and closes its proximal end 36 to preventcontamination to the main lumen 34 of the catheter and prevent liquiddrainage from the catheter while the catheter is disconnected from thedrainage tube. Once the closure caps are in position, as shown in FIG.7, the patient is free to leave the bedside, for example, to have anX-ray taken, without the necessity of transporting the drainage tube andcollection bag with the patient. Since the sterilized caps are removedfrom a sterile package and are placed in position without the necessityof touching the caps with the hands, it is apparent that the caps areplaced on the drainage tube and catheter in an aseptic manner, such asto minimize the possibility of contamination to the system. Aspreviously noted, once the caps are in position, they preventcontamination to the system while the catheter remains disconnected fromthe drainage tube.

Although the package 18 was described in connection with FIG. 3 as beingopened from one end to expose the female end 14a of the nested caps, itis apparent that the opposite end of the package 18 could be opened toexpose the male end 16b of the nested caps for use. In accordance withthis procedure, the male end 16b of the nested caps is first insertedinto the proximal end 36 of the catheter 30, the nested caps are removedfrom the package 18 by the catheter 30, and the female end 14a of thenested caps is then positioned on the distal end 40 of the drainage tube32. The caps are then separated from each other, as previouslydescribed.

When it is desired to reconnect the catheter 30 to the drainage tube 32,the cap 10a is removed from the dis tal end 40 of the drainage tube 32,and the cap 10b is removed from the proximal end 36 of the catheter 30,as shown in FIGS. 8 and 9, respectively. As illustrated in FIG. 10, thedistal end 40 of the drainage tube 32 is then inserted into the proximalend 36 of the catheter 30 to establish communication of the lumens 34and 38 and permit further use of the drainage system. The closure caps10a and b may then be discarded. However, since the male end 16b of theclosure cap 10b may be moist due to drainage of liquid in the main lumenof the catheter while the cap 10b is in place on the catheter, the maleend 16b of the closure cap 10b may be inserted into the female end 14aof the cap 10a to cover the moist male end 16b of the cap 10b prior todisposal, if desired.

The closure caps 10a and b may be made of any suitable material, such asplastic. However, if a relatively rigid connector 42 is used on thedrainage tube 32, it

is desirable to make the inner cap 10a of a softer material than theouter cap 10b and the connector 42. With such a construction of theclosure caps, the relatively soft connector 10a readily engages the morerigid con nector 42, while the relatively hard cap 10b readily grips thesofter inner cap 10a. Thus, in a preferred embodiment, the softer innercap may be made of a low density polyethylene, while the outer morerigid cap 10b may be made of a medium density polyethylene. However,satisfactory operation of the closure caps 10a and b is also obtainedwhen they are made from identical materials.

The foregoing detailed description is given for clearness ofunderstanding only, and no unnecessary limitations should be understoodtherefrom, as modifications will be obvious to those skilled in the art.

I claim:

1. A method of aseptically protecting the interconnectable ends of firstand second tubes in a liquid drainage system with a nestable pair ofsterile caps, with the nested caps having a female end and a male end,comprising the steps of:

disconnecting the ends of the first and second tubes;

inserting the end of the second tube into the female end of the sterilenested caps and the male end of the sterile nested caps into the end ofthe first tube to close the ends of the first and second tubes;

separating the nested caps, whereby the ends of the disconnected firstand second tubes are aseptically closed by the caps.

2. The method of claim 1 wherein the end of the second tube is insertedinto the nested caps prior to inserting the nested caps into the firsttube.

3. The method of claim 2 wherein the nested caps are retained in asterile package, and including the steps of:

opening the sterile package; and

removing the sterile nested caps from the opened package with the secondtube after inserting the end of the second tube into the female end ofthe nested caps.

4. The method of claim 1 wherein said first tube comprises a catheterhaving a main lumen, said second tube comprises a drainage tube having adrainage lumen which communicates with said lumen when the catheter anddrainage tube are connected, the distal end of the drainage tube isinserted into the female end of the nested caps, and the male end of thenested caps is inserted into the main lumen of the catheter adjacent itsproximal end.

S. The method of claim 4 wherein said drainage tube includes a connectoradjacent its distal end, and said connector is inserted into the femaleend of the nested caps.

6. The method of claim 1 wherein each of said caps has a male and afemale end, and the male end of an inner cap is nested in the female endof an outer cap.

a drainage tube having a drainage lumen and a connector adjacent itsdistal end;

a pair of sterile nested closure caps, with the nested caps having afemale end removably receiving and closing said drainage tube connector,with the nested caps having a male end removably inserted into the mainlumen of the catheter to close its proximal end, and with said capsbeing separable to asceptically close the ends of the catheter anddrainage tube.

10. The drainage system closure means of claim 9 wherein each of saidclosure caps has a male end and a female end, and the male end of atleast one of said caps is separably nested in the female end of theother of the caps.

11. The drainage system closure means of claim 10 wherein each of saidcaps comprises a hollow generally conically shaped member.

12. The drainage system closure means of claim 10 wherein the closurecap which is nested inside the other cap is less rigid than said othercap.

13. The drainage system closure means of claim 10 wherein the male endof either of said caps is nestable in the female end of the other of thecaps.

1. A method of aseptically protecting the interconnectable ends of firstand second tubes in a liquid drainage system with a nestable pair ofsterile caps, with the nested caps having a female end and a male end,comprising the steps of: disconnecting the ends of the first and secondtubes; inserting the end of the second tube into the female end of thesterile nested caps and the male end of the sterile nested caps into theend of the first tube to close the ends of the first and second tubes;separating the nested caps, whereby the ends of the disconnected firstand second tubes are aseptically closed by the caps.
 2. The method ofclaim 1 wherein the end of the second tube is inserted into the nestedcaps prior to inserting the nested caps into the first tube.
 3. Themethod of claim 2 wherein the nested caps are retained in a sterilepackage, and including the steps of: opening the sterile package; andremoving the sterile nested caps from the opened package with the secondtube after inserting the end of the second tube into the female end ofthe nested caps.
 4. The method of claim 1 wherein said first tubecomprises a catheter having a main lumen, said second tube comprises adrainage tube having a drainage lumen which communicates with said lumenwhen the catheter and drainage tube are connected, the distal end of thedrainage tube is inserted into the female end of the nested caps, andthe male end of the nested caps is inserted into the main lumen of thecatheter adjacent its proximal end.
 5. The method of claim 4 whereinsaid drainage tube includes a connector adjacent its distal end, andsaid connector is inserted into the female end of the nested caps. 6.The method of claim 1 wherein each of said caps has a male and a femaleend, and the male end of an inner cap is nested in the female end of anouter cap.
 7. The method of claim 1 including the steps of: removing thecaps from the ends of the first and second tubes; and connecting theends of the first and second tubes.
 8. The method of claim 7 includingthe step of inserting the male end of the cap removed from the firsttube into the female end of the other removed cap.
 9. A liquid drainagesystem closure means, comprising: a catheter having a main lumen and aproximal end; a drainage tube having a drainage lumen and a connectoradjacent its distal end; a pair of sterile nested closure caps, with thenested caps having a female end removably receiving and closing saiddrainage tube connector, with the nested caps having a male endremovably inserted into the main lumen of the catheter to close itsproximal end, and with said caps being separable to asceptically closethe ends of the catheter and drainage tube.
 10. The drainage systemclosure means of claim 9 wherein each of said closure caps has a maleend and a female end, and the male end of at least one of said caps isseparably nested in the female end of the other of the caps.
 11. Thedrainage system closure means of claim 10 wherein each of said capscomprises a hollow generally conically shaped member.
 12. The drainagesystem closure means of claim 10 wherein the closure cap which is nestedinside the other cap is less rigid than said other cap.
 13. The drainagesystem closure means of claim 10 wherein the male end of either of saidcaps is nestable in the female end of the other of the caps.